Good Clinical Practices

Using EasyMedStat ensures that you work in a secured technological frame.

However, there are some good clinical practices that you should follow to ensure that your research respects your patients fundamental rights.

These practices may not be directly related to the use of EasyMedStat, but we would like to be sure that you conduct your research properly.

You will find below some information that may help you.

Almost all clinical researches require that you ask a written consent to the patients before collecting data.

If you do not know whether or not you need to ask for consent, you probably should ask it.

If you perform a clinical trial, your consent form and your information letter should obtain approval/favourable opinion from the ethic committee or institutional review board.

The consent must be obtained from the patient himself. If the patient is unable to provide an informed consent, this consent should be obtained from a legally acceptable representative.

The patient should be provided sufficient time to ask questions and to decide whether or not s.he will participate in the study.

Provide patients with oral and written information about the research you are conducting.

Use simple language to explain:

• Why you are conducting this clinical research
• The expected duration of the patient's participation
• The procedures associated with this research
• That the participation is voluntary and that the patient may obtain treatment without participating in the study
• Who organizes the study
• Risks, discomforts or disadvantages related to the study
• Expected benefits to the patient or to other patients
• Alternative procedures if any
• How you will ensure data privacy
• How you will handle incidental findings
• Who to contact if required
• That the patient can withdraw at any time and how he could do it
• How are data managed at the end of the trial
• What will happen to the results of the research

You can get more information on this topic:

European Commission: ethical review guidance

Please check our page in french language for more information

Please check our page in french language for more information

• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines for Good Clinical Practice E 6 (R2) : https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-6-r2-guideline-good-clinical-practice-step-5_en.pdf
• A great source of information (in French): https://kernosoft.fr/RTFM/
• Health Data Hub Starter Kit (in French): https://www.health-data-hub.fr/starter-kit